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Head and Neck CancerPhase 2NCT00100789

S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer

A Phase 2 study testing gemcitabine and paclitaxel in people with Head and Neck Cancer, run by SWOG Cancer Research Network at 123 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
gemcitabine and paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
123 sitesUnited States
Study dates
Jan 2005to Feb 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN)
  • Recurrent, persistent, or newly diagnosed metastatic disease
  • Measurable or non-measurable disease
  • No active or prior CNS metastasis

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No serious organ dysfunction
  • No serious comorbid conditions that would preclude study treatment
  • No history of hypersensitivity reaction to products containing polysorbate 80
  • No active infection requiring systemic antibiotic therapy
  • No symptomatic sensory neuropathy ≥ grade 2
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent biologic or immunotherapy for SCCHN
  • No concurrent gene therapy for SCCHN

Chemotherapy

  • No prior chemotherapy for recurrent or newly diagnosed metastatic disease
  • At least 6 months since prior induction or adjuvant chemotherapy
  • No more than 1 prior induction or adjuvant regimen
  • No prior gemcitabine or taxanes as part of induction, adjuvant, or neoadjuvant chemotherapy
  • No other concurrent chemotherapy for SCCHN

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 28 days since prior radiotherapy and recovered
  • No concurrent radiotherapy for SCCHN

Surgery

  • Not specified

Other

  • No other concurrent therapy for SCCHN

Trial locations and contacts

123 sites in 1 country.

123 sites in 1 country

United States123 sites

  • Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Northeast Alabama Regional Medical Center

    Anniston, Alabama, 36202

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Aurora, Colorado, 80045

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare

    Billings, Montana, 59101

  • Billings Clinic Cancer Center

    Billings, Montana, 59107-5100

  • Deaconess Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • St. James Community Hospital

    Butte, Montana, 59701

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63701

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Roper St. Francis Cancer Center at Roper Hospital

    Charleston, South Carolina, 29401

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Center for Cancer Medicine and Blood Disorders, PA

    El Paso, Texas, 79902

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Gape Girardeau, Missouri, 63701

  • Adirondack Cancer Care - Glens Falls

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Spectrum Health Hospital - Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Metro Health Hospital

    Grand Rapids, Michigan, 49506

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Veterans Affairs Medical Center - Hines

    Hines, Illinois, 60141

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Cancer Research Center of Hawaii

    Honolula, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Lusitana

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii, 96817

  • St. Francis Medical Center

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Community Oncology Group at Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • UMC Southwest Cancer and Research Center

    Lubbock, Texas, 79415-3364

  • Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

    Martinsville, Virginia, 24115

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Community Medical Center

    Missoula, Montana, 59801

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36652-2144

  • Montrose Memorial Hospital Cancer Center

    Montrose, Colorado, 81401

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Hackley Hospital

    Muskegon, Michigan, 49442

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Sentara Cancer Institute at Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26102

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Legacy Emanuel Hospital and Health Center & Children's Hospital

    Portland, Oregon, 97227

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • Group Health Central Hospital

    Seattle, Washington, 98104-1387

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • North Puget Oncology at United General Hospital

    Sedro-Woolley, Washington, 98284

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Christus Schumpert Cancer Treatment Center

    Shreveport, Louisiana, 71101

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Pearlman Comprehensive Cancer Center at South Georgia Medical Center

    Valdosta, Georgia, 31603

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington, 98668

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wilson Medical Center

    Wilson, North Carolina, 27893-3428

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Cleveland Clinic - Wooster

    Wooster, Ohio, 44691

Other trials in United States

About this study

Official title: A Phase II Study of Biweekly Gemcitabine and Paclitaxel (GEMTAX) Combination in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.

Read the detailed description

OBJECTIVES:

  • Determine overall and progression-free survival probability in patients with persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and paclitaxel.
  • Determine the confirmed and unconfirmed response (partial and complete) probability in patients with measurable disease treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.

Patients are followed every 8 weeks until disease progression, every 6 month for 2 years, and then annually for 1 year.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 10-13 months.

Being tested
gemcitabine, paclitaxel
Keywords
Recurrent, stage IV, squamous cell carcinoma, hypopharynx, larynx, lip, oral cavity, nasopharynx, oropharynx, paranasal, nasal cavity, metastatic, neck cancer
Medical subject headings
Head and Neck Neoplasms, Recurrence, Carcinoma, Squamous Cell, Laryngeal Diseases, Lymphoid Interstitial Pneumonia, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gemcitabineDrug

    Also called Gemzar, NSC-613327

    3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).

  • paclitaxelDrug

    Also called Taxol, NSC-673089

    150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine

Study groups in NCT00100789
Study groupRoleWhat they receive
gemcitabine paclitaxel combinationExperimentalNot described
Receives: Drug: gemcitabine; Drug: paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

    Measured: 0 - 3 years

Secondary outcomes (3)

  1. Progression-free Survival

    Measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.

    Measured: 0 - 3 years

  2. Response

    Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other normal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.

    Measured: 9 weeks - 3 years

  3. Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

    Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

    Measured: Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00100789
Sponsor's protocol ID
CDR0000407644
Other IDs
S0329, U10CA032102
Status last verified
Aug 2012
First submitted
6 Jan 2005
Last updated
1 Oct 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine and paclitaxel in people with Head and Neck Cancer, run by SWOG Cancer Research Network at 123 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 0 - 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00100789.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2012.

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